Dr. Shobha Swaminathan is an associate professor at Rutgers New Jersey Medical School and medical director of infectious diseases practice at University Hospital. This week, she is better known for being the principal investigator for the Moderna Phase 3 coronavirus vaccine clinical trial at the school.
On Monday, Moderna announced its vaccine had a 94.5% efficacy rate — the second incredibly positive vaccine announcement in the last 10 days.
Swaminathan, who has been involved in a handful of vaccine studies, twice serving as the principal investigator, gave ROI-NJ some insights into how this trial was different from the others in speed and size — and why concerns about safety may be unfounded.
Here’s a look at the conversation, edited for clarity and space.
ROI-NJ: Let’s start with the basics: How big was this trial overall — and how big was the trial you oversaw in Newark?
Shobha Swaminathan: There were more than 90 sites in the U.S., enrolling more than 30,000 participants. The Rutgers New Jersey Medical School is one of two sites in New Jersey. I am the principal investigator at the site, which means I’m responsible for the conduct of research activities in our unit. We enrolled 57 people.
ROI: The study had an equal number of people who got the vaccine and got the placebo — do you know the breakdown of the 57 people in your trail?
SS: No. It is a blind study.
ROI: What can you tell us about your participants and the participants overall?
SS: The study included a very diverse representation of clinical trial participants, people from different racial and ethnic minorities. And the study made sure to include senior citizens, because the vaccine should be safe and effective among those most vulnerable — and senior citizens have been one of those who’ve been mostly impacted by the pandemic.
It might be easier to get a young, healthy person who has no underlying risk factors, but it’s critical that we enroll the people who have the highest risk. We spoke to a number of senior citizen groups and came up with ways to engage them more effectively to help with recruitment for that study. As a result, there were close to 8,000 people in the study — so, approximately 25% of the group — who were over 65 years.
ROI: Of course, getting anyone to sign up to study can be difficult. Many do not want to subject themselves to any potential dangers or side effects. Because this study happened so quickly — in a matter of months instead of the normal 5-10 years — should the general public be concerned that safety was compromised?
SS: Some people have expressed concerns that the pace of vaccine development is progressing so rapidly that they are uncomfortable, because they feel it going too fast. And they feel that there is a perception that there is speed at the cost of participant safety. What we’ve said all along is: While Phase 3 studies are being conducted in parallel with vaccine manufacturing and the Phase 3 studies have only occurred once, we have Phase 1 and Phase 2 safety information. So, it’s not like there is none. Now, clearly, we don’t have long-term safety data. But there is certainly safety information available and participants in the Phase 1 and Phase 2 and Phase 3 studies are still being followed for any long-term safety data.
Being in a pandemic has necessitated this, because I don’t think we, as a society, can continue to live in complete lockdown for two years. So, we’re trying to walk that fine line between ensuring vaccine safety and efficacy, while also addressing concerns. And that comes with education, too. So, people need to be aware of the checks and balances in the clinical trial process to ensure participant safety.
ROI: You mention education. Most people have no idea of the size, scope and time that trials usually take. Compare this to the other trials you have been a part of.
SS: In a conventional mode, companies are the ones who usually start the process. They have to spend a lot of time vetting vaccine candidates, and then they have to do an entire risk analysis to figure out, is it worth the investment, because the companies are on their own investing billions of dollars into put into preclinical studies or animal studies, as applicable.
Then, they get into Phase 1 studies, which typically take a year or two; then, Phase 2 studies, which take another two years. And then, Phase 3 studies, which may take another two or three years. So, most vaccine studies are about five to 10 years in development, in large part because it takes a lot of time to accrue the participants. It takes a lot of funding investment. Companies, in general, are risk averse.
In this case, the NIH funded Operation Warp Speed and various other branches of the government have partnered with the industry and essentially are taking on the bulk of the risk.
ROI: But, still, how do you go from 10 years to 10 months?
SS: The clinical trial sizes have increased significantly. A typical vaccine study frequently has a few thousand, typically less than 5,000 participants enrolled. But, this is 10 times that. There are studies from 30,000 to 60,000 participants. By increasing the sample size so much, we are decreasing the amount of time required to be able to accrue those events.
Let’s take the Moderna vaccine trial. We observed 95 cases in 30,000 participants. If we only had 3,000 participants, it might take 10 times longer. So, by increasing the sample size, you’re able to answer the questions in a much more expedited manner.
ROI: Everyone wants to compete. Scientists and researchers are no different. There are about a dozen vaccine trials taking place around the world. Moderna is the second to report. Is there a race to the finish line — and any advantage of getting there first?
SS: Not really, because I think there’s definitely going to be more than one vaccine. And we will need multiple vaccines, because no one vaccine and no one company can effectively provide enough vaccine for the entire global population, because everybody on this Earth has been affected by the pandemic.
Secondly, different vaccines may be more easily deployable in different situations in different countries, depending on their storage and transportation and temperature requirements.
Third, different vaccines may work differently in select subpopulations. Now, this is speculation, I haven’t seen the data, but it’s possible some vaccines may be better in senior citizens, or some vaccines may be better in people with certain underlying health conditions. So, we don’t know those nuances between these different vaccines.
ROI: You have been a part of a handful of vaccine trials. And all vaccines and medical breakthroughs are important. Talk about the added significance there must be to be a part of a trial to help find a vaccine for COVID-19.
SS: I think there’s definitely a bigger sense of urgency, because, unlike some of the other vaccines — like the HPV vaccine — we may not always feel personally connected, may not be sure it’s going to impact me. This impacts everybody.
ROI: Final question: Tell us one way this vaccine trial has been different that we haven’t thought of?
SS: I think performing these clinical trials while there’s a pandemic that is raging has brought some logistical challenges. We have had to make sure we maintain the safety of our participants and the staff while we do the work we do. We don’t have the luxury of being able to work remotely. We have to come in and see these participants (and) administer the study products.
I really want to acknowledge my research team and all our participants for really stepping up to the challenge. And all of us owe a big ‘thank you’ to the participants of all these vaccine studies. They have chosen to be part of the answer (with) a willingness to come and help find the answer to this global pandemic.